Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B

This study is currently recruiting participants.

Verified June 2011 by Chulalongkorn University

Sponsor:

Information provided by:

Chulalongkorn University

ClinicalTrials.gov Identifier:

NCT01243281

First received: November 17, 2010

Last updated: June 26, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2010

Last Updated Date

June 26, 2011

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To determine whether a combination of PEG-IFN and entecavir improves the rate of sustained response and HBsAg clearance in patients with HBeAg-negative chronic hepatitis B [ Time Frame: 24 weeks post treatment ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01243281 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine host factors and viral factors associated with response to PEG-IFN alone or PEG-IFN plus entecavir treatment [ Time Frame: 24 weeks post treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B

Official Title ^ICMJE

A Randomized Design Study to Compare the Efficacy of Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B: Role of Host and Viral Factors Associated With Treatment Response

Brief Summary

The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate. In addition, the simultaneous assessment of viral and host genetic factors associated with SVR may help to identify predictors of treatment outcomes, which will in turn significant reduce the cost/effect of therapy

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Hepatitis B

Intervention ^ICMJE

Drug: PEG-IFN and entecavir

The patients will be randomized in approximately 1:1 ratio into one of 2 treatment regimens; to receive PEG-IFN alpha-2b (1.5 microgram/kg/week) plus entecavir (0.5 mg/day) or PEG-IFN alpha-2b (1.5 microgram/kg/week) alone for 48 weeks by using pre-generated randomization schedule.

Other Names:

pegintron
baraclude

Study Arm (s)

Active Comparator: drug combination

Intervention: Drug: PEG-IFN and entecavir

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

126

Estimated Completion Date

December 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Men and women 18 to 65 years of age
Patients with HBeAg-negative chronic hepatitis B
Positive for HBsAg for at least 6 months, negative for anti-HBs and HBeAg
Serum HBV DNA levels ≥ 2,000 IU/mL at screening
Increased alanine aminotransferase (ALT) levels [greater than the upper limit of normal (ULN) and less than 10xULN}
No signs or symptoms of advanced liver disease
Patient has had a liver biopsy within 1 year of screening

Exclusion Criteria:

Patient had previous treatment with IFN, peg-IFN, and/or entecavir
Patient has evidence or history of chronic hepatitis not caused by HBV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
Patient has co-infection with hepatitis C virus and/or human immunodeficiency virus
Patients with liver cancer
Female patient is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential throughout treatment.
Patient has any other condition that is contraindicated for treatment with PEG-IFN or entecavir
Patient has any condition or pre-study laboratory abnormality, or history of any illness, which in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drug

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pisit Tangkijvanich, M.D.

+662-256-4482

pisittkvn@yahoo.com

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01243281

Other Study ID Numbers ^ICMJE

Biochem2010/01

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Pisit Tangkijvanich, Faculty of Medicine, Chulalongkorn University

Study Sponsor ^ICMJE

Chulalongkorn University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Pisit Tangkijvanich, M.D.

Chulalongkorn University

Information Provided By

Chulalongkorn University

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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